Health product recall

Philips Respironics BiPAP and Humidifiers

Last updated

Summary

Product
Philips Respironics BiPAP and Humidifiers
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

BiPAP A30 System - Ventilator & System One A-Series Heated Humidifier

All lots.

1111148

BiPAP A40, Canada

All lots.

1109596 1111173 1111174

BiPAP A40 Pro, Ca

All lots.

CAX3100S12

BiPAP A30 System

All lots.

1111147

BiPAP A40 Pro, CA W/ Heated Tube Humidifier, CA

All lots.

CAX3100T12

Issue

The affected products feature a ventilator inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. this may manifest in the following ways:

  • The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy with same patient settings.

or

  • The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy but with factory default settings.

or

  • When there are three (3) reboots within a 24-hour period, the device will enter a ventilator inoperative state (therapy stopped, audible and visual alarms present).

or

  • The device may enter a ventilator inoperative state without a reboot preceding this condition.

Any of the above scenarios could result in interruption and/or loss of therapy which may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Recall start date: March 19, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Respironics Inc. Also Trading As Philips Rs North America LLC

1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75470

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